CLA-2-84:OT:RR:NC:N1:105
Carlos Sanchez
Ortho Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626
RE: The tariff classification of an Ortho Workstation Immunohematology Analyzer from the United States
Dear Mr. Sanchez:
In your letter dated March 17, 2025, you requested a tariff classification ruling. Descriptive literature was
provided for our review.
The item under consideration is the Ortho Workstation Immunohematology Analyzer, which is a combined
2-in-1 blood testing system providing both incubation and centrifugation in one machine. Despite being
called an analyzer, the device itself does not perform any analyzing function and instead solely performs the
incubation (keeping the specimen at a controlled temperature) and centrifugation (performing the separation
of the specimen). The composite machine utilizes ID-Micro Typing System (ID-MTS) Gel Card Column
Agglutination Technology, which utilizes cards consisting of microtubes prefilled with gel particles, diluent,
and appropriate antisera. This is used for blood grouping, antibody screening, and identification and
cross-match testing. The Ortho Workstation is designed for laboratory use and features incubator temperature
monitoring with a visual indicator, a unique beeping pattern to indicate cycle completion, enhanced error
code intelligence for troubleshooting, and a quiet centrifuge with translucent panels for visual monitoring.
The device measures 8.66 inches high by 22.64 inches wide by 12.80 inches deep and weighs 24 pounds. In
your letter, you state the Ortho Workstation Immunohematology Analyzer, despite being of U.S. origin, will
be imported into the United States.
Section XVI, Note 3, Harmonized Tariff Schedule of the United States (HTSUS), states, in relevant part, that
“machines designed for the purpose of performing two or more complementary or alternative functions are to
be classified as if consisting only of that component or as being that machine which performs the principal
function.” In addition, General Explanatory Note (VI) to Section XVI states, with respect to multi-function
machines and composite machines, that where it is not possible to determine the principal function and
where, as provided in Note 3 to Section XVI, the context does not otherwise require, it is necessary to apply
General Rule of Interpretation (GRI) 3(c). GRI 3(c) requires classification in the last heading from among
those which equally merit consideration. In this case, it is our opinion that both the centrifuge function and
the incubator function are of equal merit. Thus, the two headings which merit equal consideration are heading
8421, HTSUS, which provides for the centrifuge for separating the specimen and heading 8419, HTSUS,
which provides for the incubator (keeping the specimen at a controlled temperature). As there is no one
principal function, the Ortho Workstation Immunohematology Analyzer is classifiable in accordance with
GRI 3 (c), which is the last heading from among those that equally merit consideration, i.e., heading 8421,
HTSUS.
Accordingly, as you suggest in your letter, the applicable subheading for the Ortho Workstation
Immunohematology Analyzer will be 8421.19.0000, HTSUS, which provides for ?Centrifuges, including
centrifugal dryers; filtering or purifying machinery and apparatus, for liquids or gases; parts thereof:
Centrifuges, including centrifugal dryers: Other.? The general rate of duty will be 1.3 percent ad valorem.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS
and the accompanying duty rates are provided at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Jason Christie at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division